1. Field of the Invention
The present invention relates to a process of manufacturing an expandable member such as a tissue expander and other medical and surgical products, such as used in plastic, reconstructive, and other surgery. Such products, as tissue expanders are made from silicone or other suitable pliable material with an intended non-stick member, and have a chamber which can be filled with fluid after the expander is positioned in the appropriate surgical location.
2. Description of the Prior Art
Prior art tissue expanders have been fabricated by coating a mandrel and after curing, removing the formed product. Subsequent operations include the gluing of tubing in place. Such devices have been prone to fail by breaking at the glued seam, and allowing the fluid to leak from the expander into the adjacent tissue. This not only causes the loss of expansion but can have harmful effects on the patient. Some expanders have been made without seams in a fashion similar to balloons. Such expanders lack dimension stability during insertion, making such very difficult to properly position in the tissue. This same lack of dimensional stability in like products tends to cause such expanders to expand in typical balloon-like fashion, which seldom is in the desired shape.
This invention provides a tissue expander with dimensional stability and reliability of a one-piece assembly having a thin layer of non-sticking material imbedded about the region where expandability is desired.